The ME Association believes that energy management, which involves both physical and mental activity, is the most important aspect of managing ME/CFS.

Consequently, we welcome research which aims to improve our knowledge of how this can best be achieved.

Energy management programmes must be individually tailored. And they have to take account of the wide range of clinical presentations and disease pathways that come under the ME/CFS umbrella.

We are therefore very critical of over-simplistic exercise regimes which are based on deconditioning, fear of activity and the assumption that people just need to ‘try harder’ in order to get better. Many people with this condition are, in fact, performing at or near their maximum capacity. And some need to actually reduce their activity levels and stabilise their condition before starting any form of increase in activity levels.

In addition, the approach being recommended does not acknowledge the muscle, brain and immune system abnormalities in ME/CFS, which help to provide a physical explanation for the debilitating central (brain) and peripheral (muscle) fatigue that occurs in this illness.

Feedback from patients, who are not normally treated as part of research studies, consistently indicates that around 25% find exercise programmes to be of no value. Around 50% report that their condition worsens as a result.

So the real reason why cognitive behaviour therapy and graded exercise therapy are not producing significant benefits across the whole ME/CFS population is that they are based on a flawed model of illness causation. They are are not taking account of the medical complexities involved.

In our experience, patients with ME/CFS are highly motivated to get better.

They are very willing to take part in energy management programmes that establish a safe baseline of activity, take account of the stage and severity of their illness, involve increases in physical and mental activity that are gradual, flexible and do not result in the person going beyond their limitations and causing symptom exacerbation.

We fear that the way the results of this study are being presented in the media and in the medical press will be interpreted to reinforce the over-simplistic and misguided view that rest is bad and exercise is good for people with ME/CFS.

And without discussing the medical complexities involved, people are then led to the conclusion that any reluctance to progressively increase activity levels is far more related to fear or avoidance behaviour than any underlying disease process.

What we desperately need are high quality research studies that are aimed at producing a range of individual energy management programmes based on clinical presentation, stage, and severity of illness.

Reducing worry that exercise or activity will worsen symptoms of chronic fatigue syndrome (myalgic encephalomyelitis or ME) is important for the success of cognitive behavioural therapy or graded exercise therapy in reducing fatigue and improving physical function, concludes a new analysis of data from the PACE trial, reported in the Lancet Psychiatry.1

Earlier results from the PACE (adaptive pacing, graded activity, and cognitive behaviour therapy—a randomised evaluation) trial, published in the Lancet in 2011, showed that in a group of 641 patients cognitive behavioural therapy (CBT) and graded exercise therapy (GET) were of more benefit at 52 weeks to people with chronic fatigue syndrome than adaptive pacing therapy (APT) and usual specialist medical care.2

In GET the patient undertakes a personalised and gradually increasing exercise programme delivered by a physiotherapist, whereas in APT the patient adapts their activity levels to the amount of energy they have.

Trudie Chalder, professor of cognitive behavioural psychotherapy at King’s College London, said that although the original PACE trial results indicated that CBT and GET offered safe and effective treatment options for most patients with chronic fatigue syndrome, the improvements seen were moderate. “By identifying the mechanisms whereby some patients benefit from treatment, we hope that this will allow treatments to be developed, improved, or optimised,” she said.

The researchers used mediation analysis to identify the factors—such as physical fitness (as measured by a walking test) and beliefs about activity—through which CBT and GET achieved their beneficial effects on fatigue and overall physical function. These potential mediating factors were measured at 12 weeks, halfway through the patients’ 24 weeks of treatment, except for the walking test, which was assessed at 24 weeks.

Of the factors they analysed, the researchers found that a reduction in fear that exercise or activity would make the symptoms worse (fear avoidance beliefs) had the largest mediated effect on fatigue and physical function in the case both of CBT and GET (standardised effect ×10 for fatigue, CBT versus APT: −1·22 (95% confidence interval −0·52 to −1·97); GET versus APT: −1·86 (−0·80 to −2·89); for physical function, CBT versus APT: 1·54 (0·86 to 2·31); GET versus APT: 2·35 (1·35 to 3·39)). These factors accounted for 51% of the overall effect on physical function for GET and 37% for CBT, when compared with APT. The respective proportions were 61% and 34% for the same comparisons for the effect on fatigue.

Increase in exercise tolerance (metres walked during a six minute walk) was a potent mediator of the effect of GET, when compared with APT (standardised effect ×10 for fatigue: −1·37 (−0·76 to −2·21); for physical function: 1·90 (1·10 to 2·91)), but not CBT.

Other factors, including avoidance of activity, damage beliefs, and catastrophising, were weaker mediators of the effects on fatigue and physical function.

Chalder said, “Our results suggest that fearful beliefs can be changed by directly challenging such beliefs (as in CBT) or by simple behaviour change with a graded approach to the avoided activity (as in GET). Clinically, the results suggest that therapists delivering CBT could encourage more physical activity such as walking, which might enhance the effect of CBT and could be more acceptable to patients.”

The original 2011 study attracted much criticism over its definitions of secondary outcomes, protocol changes, and generalisability, and the results were disputed. Charles Shepherd, an honorary medical adviser to the ME Association, said that evidence from patients collected by the society indicated that “most people with ME/CFS find CBT to be ineffective (or even harmful); around half consistently report that GET makes them feel worse; and the vast majority report that pacing is the most acceptable and effective form of activity management.”3

Chalder said it was important, because individual experiences of the condition were highly variable, that exercise was personalised to the patient and then introduced gradually. “The most important thing is that right at the very beginning when you do the assessment you find out what the person is able to do and then work from there,” she told a press conference.

“On a day when they feel less symptomatic and very energetic they may do more than they are probably able to do and then of course suffer as a consequence. What we try and do is level out their activities so that [they are] more even and more distributed across the week and the day.”

T
The researchers used mediation analysis to identify the factors—such as physical fitness (as measured by a walking test) and beliefs about activity—through which CBT and GET achieved their beneficial effects on fatigue and overall physical function. These potential mediating factors were measured at 12 weeks, halfway through the patients’ 24 weeks of treatment, except for the walking test, which was assessed at 24 weeks.

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I think that physical fitness was measured by the results of a step test being fed into a formula that include weight or bmi.

Combining a cacophony of vague symptoms, with even less in the way of overt clinical signs is, I suppose, one way of achieving fame, by having one's name attached to a new disease or syndrome?

What is the incidence and prevalence of so-called chronic fatigue syndrome (CFS)/Myalgic Encehaphlo-myelitis(ME) in less developed countries? Does it actually exist in less industrial societies. If there is a significant difference in incidence and prevalence, then why?

Could it be a genetic variation, is it in the diet, are there certain toxins present in the UK for example, that may not be present, for example, in Tanzania?

Or are we looking at a peculiarly first world problem, symptomatic of the toxicities of their societies, where stress has become the order of the day, social isolation, a disconnect from where we have all come i.e. the land, the soil, the trees, the environment, and destruction of the extended society? And this has led to a society swamped by mental health issues, possibly masquerading as CFS/ME.

Exercise, out-door activities, and reintroduction into the natural environment may well be the treatment society requires to prevent it from self-destruction. Oh, and the odd anti-depressant / mood stabiliser.

The ME Association believes that energy management, which involves both physical and mental activity, is the most important aspect of managing ME/CFS.

Consequently, we welcome research which aims to improve our knowledge of how this can best be achieved.

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I for one don't think yet more research on managing the condition is to be welcomed, I know how to manage my limited energy already, as I'm sure most suffers do. You should be telling them to stop wasting money on this kind of research, and spend the money on biomedical research instead.

So this BMJ respondent has constructed/reduced ME sufferers to the level of a threatening symptom of a toxic, alienated, stressed out society that has lost its connection with nature and fundamental healthy values. Also as a early warning sign of as society hell bent on self destruction. Sounds like this guy's been reading too much Rousseau, and thinks ME sufferers are largely responsible for corrupting the natural purity of the 'natural man'.

Pass the sick bucket.

BMJ Response:
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"...Or are we looking at a peculiarly first world problem, symptomatic of the toxicities of their societies, where stress has become the order of the day, social isolation, a disconnect from where we have all come i.e. the land, the soil, the trees, the environment, and destruction of the extended society? And this has led to a society swamped by mental health issues, possibly masquerading as CFS/ME.

Exercise, out-door activities, and reintroduction into the natural environment may well be the treatment society requires to prevent it from self-destruction. Oh, and the odd anti-depressant / mood stabiliser."
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I pity the PWME who are that man's patients. Where has he been all his life? How do people as ignorant and complacent as that manage to stay as doctors for more than a day or two? The man needs to be shown the door with a reassuring pat on the head and a bunch of "mood stabilizers". If we talked unsubstantiated mumbo jumbo like that we'd be done for, and yet a doctor seemingly is free to do so.

I for one don't think yet more research on managing the condition is to be welcomed, I know how to manage my limited energy already, as I'm sure most suffers do. You should be telling them to stop wasting money on this kind of research, and spend the money on biomedical research instead.

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Reply:

Don't agree!

One of the key reasons why it's difficut to challenge the claims relating to GET is that we don't really have any sound 'evidence based medicine' with results from large robust and replicated clinical trials that support the view of patients that pacing is the most effective and safe form of activity/energy management for people with ME/CFS. Simply trying to make our case using patient evidence - ie the sort of large scale patient surveys that the MEA carries out and publishes - just isn't good enough.

Secondly, we do need data on why some people with ME/CFS (myself included) have been able to progressively increase their physical and mental activity levels (without the use of drugs, diet, supplements, magic cures etc) whereas others are just not able to do so - despite very strong motivation. We then need to translate this information into practical personalised management programmes based on stage, severity and variability of symptoms.

One of the key reasons why it's difficut to challenge the claims relating to GET is that we don't really have any sound 'evidence based medicine' with results from large robust and replicated clinical trials that support the view of patients that pacing is the most effective and safe form of activity/energy management for people with ME/CFS. Simply trying to make our case using patient evidence - ie the sort of large scale patient surveys that the MEA carries out and publishes - just isn't good enough.

Secondly, we do need data on why some people with ME/CFS (myself included) have been able to progressively increase their physical and mental activity levels (without the use of drugs, diet, supplements, magic cures etc) whereas others are just not able to do so - despite very strong motivation. We then need to translate this information into practical personalised management programmes based on stage, severity and variability of symptoms.

There are other reasons as well....

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There is a question over the opportunity costs of doing this type of research vs research looking at disease mechanism. Although I think your point of why some people manage to progressively increase activity and others done is an interesting one perhaps pointing at two different mechanisms.

I guess the question is given the limited research dollars where are they best spent.

One of the key reasons why it's difficut to challenge the claims relating to GET is that we don't really have any sound 'evidence based medicine' with results from large robust and replicated clinical trials that support the view of patients that pacing is the most effective and safe form of activity/energy management for people with ME/CFS. Simply trying to make our case using patient evidence - ie the sort of large scale patient surveys that the MEA carries out and publishes - just isn't good enough..

Secondly, we do need data on why some people with ME/CFS (myself included) have been able to progressively increase their physical and mental activity levels (without the use of drugs, diet, supplements, magic cures etc) whereas others are just not able to do so - despite very strong motivation. We then need to translate this information into practical personalised management programmes based on stage, severity and variability of symptoms.

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I agree we do need proper scientific research into this, I'm also one who has progressively increased my physical activity level. However I don't for one second think these people will be able to come up with the answers by doing more of the same type of psychological research they do.

By saying you welcome more research in this area, you're giving the green light to more psychological rubbish.

What you should be doing is asking for scientific research on people like you and I, proper tests like brain imagining, exercise testing with VO2 take up, lactate levels, and all the other testing that shows markers of abnormality and looking very carefully at how and why these improvements have taken place.

One of the key reasons why it's difficut to challenge the claims relating to GET is that we don't really have any sound 'evidence based medicine' with results from large robust and replicated clinical trials that support the view of patients that pacing is the most effective and safe form of activity/energy management for people with ME/CFS. Simply trying to make our case using patient evidence - ie the sort of large scale patient surveys that the MEA carries out and publishes - just isn't good enough.

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That sounds perfectly reasonable.
Could I ask, have there been any research proposals put forward for large, robust and replicated clinical trials into the efficacy of pacing? If so has there been any corresponding willingness either expressed or intimated by the relevant funding bodies to finance such trials?

I agree we do need proper scientific research into this, I'm also one who has progressively increased my physical activity level. However I don't for one second think these people will be able to come up with the answers by doing more of the same type of psychological research they do.

By saying you welcome more research in this area, you're giving the green light to more psychological rubbish.

What you should be doing is asking for scientific research on people like you and I, proper tests like brain imagining, exercise testing with VO2 take up, lactate levels, and all the other testing that shows markers of abnormality and looking very carefully at how and why these improvements have taken place.

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Reply:

I thought it was fairly obvious from the rest of my BMJ rapid response that I want to see more research which increases our understanding of biomedical causes of central (brain) and peripheral (muscle) fatigue in ME/CFS.

I suspect you aren't from the UK.

If you are, you should be aware that I have been involved in muscle and mitochondrial function research here in the UK for the past 30 years.

Using biopsies and MRS examination of my own skeletal muscle, I was part of the first research study (published in The Lancet in 1984) in Oxford which found early and excessive production of lactic acid.

A second study at the time, lead by Professor Mina Behan, found structural abnormalities in the mitochondria when they were examined using electron microscopy.

Since then The MEA Ramsay Research Fund has funded further research at the University of Newcastle that has confirmed these findings.

We are currently funding further research into mitochondria function and possible approaches to management at the University of Liverpool (Prof Anne McArdle et al) and further research in Newcastle looking for mitochondrial DNA abnormalities.

That sounds perfectly reasonable.
Could I ask, have there been any research proposals put forward for large, robust and replicated clinical trials into the efficacy of pacing? If so has there been any corresponding willingness either expressed or intimated by the relevant funding bodies to finance such trials?

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Reply

There haven't been any large scale clinical trials carried out and published that have used pacing (as we understand it) that can be used in comparison to the Pace trial. This is a problem.

The second problem is finding a group of clinicians who use this type of pacing and want to carry out a clinical trial

The third problem is funding. This sort of trial is extremely expensive to do and is well outside the remit of research funding charities here in the UK.

I know from previous membership of the Medical Research Council Expert Group on ME/CFS that the MRC would be very willing to seriously consider such a proposal. The problem (and I know I keep using this word!) is that we don't currently have a hospital based group of acceptable clinicians who want to do a trial of pacing.

I think it's a mistake to try to work on any behavioural intervention for CFS at the moment, and that it's quite likely all of them will be worse than nothing. They would take place within the system that has enabled the past mistreatment of patients. Until fairly fundamental changes are brought about I want the NHS to have as little power and influence over the lives of patients as is possible. All the advice I've received relating to ME/CFS has been unhelpful, and deciding to dismiss it all has been the most useful thing I've done.

There haven't been any large scale clinical trials carried out and published that have used pacing (as we understand it) that can be used in comparison to the Pace trial. This is a problem.

The second problem is finding a group of clinicians who use this type of pacing and want to carry out a clinical trial

The third problem is funding. This sort of trial is extremely expensive to do and is well outside the remit of research funding charities here in the UK.

I know from previous membership of the Medical Research Council Expert Group on ME/CFS that the MRC would be very willing to seriously consider such a proposal. The problem (and I know I keep using this word!) is that we don't currently have a hospital based group of acceptable clinicians who want to do a trial of pacing.

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I think there are also some hard methodological problems in running such a trial. PACE ignored them. But how to create an adequate control and how to properly measure improvements are both hard especially with this type of technique. I think it is slightly less problematic with blinded placebo controlled trials. But there is still a question of how to measure and why different measures don't correlate.

With pacing I assume it would need to be quite a long duration trial if people are gradually improving?

I for one don't think yet more research on managing the condition is to be welcomed, I know how to manage my limited energy already, as I'm sure most suffers do. You should be telling them to stop wasting money on this kind of research, and spend the money on biomedical research instead.

One of the key reasons why it's difficut to challenge the claims relating to GET is that we don't really have any sound 'evidence based medicine' with results from large robust and replicated clinical trials that support the view of patients that pacing is the most effective and safe form of activity/energy management for people with ME/CFS. Simply trying to make our case using patient evidence - ie the sort of large scale patient surveys that the MEA carries out and publishes - just isn't good enough.

Secondly, we do need data on why some people with ME/CFS (myself included) have been able to progressively increase their physical and mental activity levels (without the use of drugs, diet, supplements, magic cures etc) whereas others are just not able to do so - despite very strong motivation. We then need to translate this information into practical personalised management programmes based on stage, severity and variability of symptoms.

There are other reasons as well....

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We do not need an “EBM” study on activity management to dispute the PACE hypothesis anymore than migraine sufferers need an “EBM” study on whether listening to extremely loud heavy metal helps there condition.

Also there are studies out there disputing PACE or at least CBT and GET namely the Belgium one.

We should not be expected to accept that because over 20 years you have improved your activity without “magic cures” that we need to waste any more time or money on activity management studies. If we are required to accept your statement of improved activity at face value then surely you understand that the overarching majority of ME sufferers cannot improve their activity levels without the necessary biomedical interventions and by making absent more nonsense trials on pure “activity management”.

What exactly would be the point of wasting any time or money on “disproving the PACE hypothesis when PACE disproved itself. It failed period. I just don’t get how we are required to validate oursleves with a pacing ourselves study when the PACE study proved GET and CBT have zero impact on improving the lives and physical condition of people with neuro immune disease. (I may not have worded than clearly). I fail to understand this logic and it is totally the opposite of the purpose of validation studies. If something costing £5 million to test a hypothesis fails to prove such a hypothesis that’s it. Just what do WE on the opposing paradigm need to prove. We just have to point out the factual data.

Not only that but it must be pointed out that the criteria used in the PACE would most likely produce a given number of “recovered” or improved people anyway over the period of a year regardless of any “interventions” or SMC. That must be factored into bullet points in responses especially to the press.

If we compare the ME Association response to the latest media onslaught to that of the Swedish ME organisation and the IinME response to the P2P it is I am afraid it is in parts frankly verging on embarrassing and weak.

I really feel that the ME Association and AFME often act like a boxer stepping into a ring and being afraid to throw a punch incase they make the opponent angry.

The problem is we are up against dirty opponents in the Wessely school. The PACE trial and many other revelations of their conduct time and time again reveal noting but shear fraud manipulation lies and spin.

It is really about time we had a 50 experts letter version of such issues as we did for the CFSAC ICC criteria issue. We need our experts to once and for all step up to the plate call a press conference and just say it like it is about the Wessely school. The man is a fraud period.

There must be at least 100 factual bullet points that can be put forward about them to prove their utter nonsense and deception over the years. Until this is done we are acting foolishly I am afraid falling time and time again for the same old trick of being caught on the defensive when they bombard the media and medical journals with, both, utter opportunist and well planned out crap and lies. We then turn to fire fighting and fall into the trap time and time again of being portrayed as being “militants and opposed to scientific endeavours. Its obvious this is the position the Machiavellians in the Wessely school want us in. Continually on the back foot.

Its really time for people like Lipkin and the fifty experts letter people to show their true colours and simply tell it like it is. If those fifty experts and Lipkin cannot pull the PACE trial apart and other nonsense like it, with one joint voice publicly, simply by pointing out clear facts and contradictions I am afraid I have lost all faith in them actually achieving any thing for us on the whole. I just find it shocking that we are told EBM is the way to disprove illusions lies and spin. It is not, the way to disprove it is to point out to the wider world and the whole scientific community, the media and the medical profession that Wessely et a al have disproved themselves.

It is kind of like cancer researchers testing whether mineral water, purified tap water or non existent SMC is the cure for cancer and then declaring one to have shown some minor reporter bias improvements in a trial costing £5 million and then going on to attract the world media’s attention to declare one water over the other as the cure for cancer whilst the rest of the scientific community sits by and lets them do it.

We don't need another “evidence based” study to test GET CBT, or any other “activity management” plan for ME any more than we need an EBM study to test if sugar is good for obesity.

We certainly don't need to test such “activity management” plans if they take 20 years to show some minor improvement and leave us still with the same condition. Many of use don’t' have 20 years left.

This post is not aimed at the individual character of any person within ME advocacy charities or organisations but it is a straight forward firm call for strategy change. It just seems such common sense to me that we do not have to sit back and wait for a “cure” or a biomarker to be discovered to once and for all on mass with our experts and Advocacy groups finally take the front foot and call press conferences etc in exactly the same way the Wessely school do. There’s no reason our experts on mass in one press conference cannot “peer review” the lies and spin put forward by Wessely et al. The difference is they are liars fraudsters and spinners, we are not.

All we ever do is get caught off guard when they dump crap on us, and the thing is its always the same crap being span as “new evidence” or proof of XY or Z. Either that or just shifting the goalposts and pushing the same flawed logic.

Until such an event happens I really feel that our experts are letting us down, and actually making it harder for themselves, by leaving much of the fire fighting to us in numerous FOI requests, comments on articles in comment sections etc etc. One, it is so taxing on us and two its way to easy for the Wessely school to spin this as “harassment by militant MEers” as they constantly do. There is also the issue of real experts not being able to get funded for quality biomedical studies because they refuse to point out the years and years worth of obvious lie fraud and flawed methodology coming from biopsychosocial school. Why would anyone fund real biomedical studies if they are constantly bombarded with unchallenged spin and lies form that BPS school in medical journals and the media.

I mean for goodness sake the evidence of their fraud, BPS model, and failed treatments is out there in black and white. Do our 50 experts from the NIH CFSAC ICC letter and others, really think the media and the scientific world outside of ME is going to go looking for that on their own. It would be like the police randomly going around looking for murders. That's not how it works . It is also the case that the Wessely school is hiding behind a protective cloak of “scientific endeavour” which the average person would see no reason to unzip.

I thing the position we are in with individual Advocates/ Charity responders is they feel like David going up against Goliath taking on a mountain of massive PR spin, the insurance industry, the DWP “austerity” issue. They also have to make quick on the back foot unprepared or perhaps under prepared replies.

I am just shocked that so many of the ME charities responses didn't even mention the fact that the IOM has called for the very criteria used in the PACE trial to be retired and why. Its a fact that this happened regardless of ones view on the matter. Its evidence in black and white. Its a massive bullet point that simply would make it difficult for a journalist to get out of context or misquote to make it mean something else.

It would, I feel, be the best strategy to put a journalist in a position to try to think for themselves to see the bigger picture rather than the journalist just running around London on company expenses going to briefings and just copying and pasting a script written for them by people like the SMC. I am under no illusion that this would definitely happen however.

I do feel that often the less said in response to a journalist is the best route as they can take a quote and place it where and how they like in any context. Also they can simply have no grasp of the overall issue. That's why a short bullet point statement of proven facts (especially on the PACE trial) would be the best way to respond time and time again.

I therefore call on, at a minimal, the 50 experts who signed the NIH CFSAC ICC letter and aslo include Ian Lipkin, to come up with, lets say 50, bullet points about the conduct of the Wessely camp, call a press conference and take the PACE trial and the Wessely school to task. If that never happens we will be sitting here in another 20 years still facing medical abuse, stigma, disability benefits attacks by companies like ATOS and ill informed nonsense being put out it in the press.